Novo Nordisk’s Combination Insulin Ryzodeg Approved in Japan

The Japanese Ministry of Health, Labor and Welfare has approved Novo Nordisk’s new combination insulin, Ryzodeg, for the treatment of diabetes.

Ryzodeg is a soluble formulation of Tresiba (insulin degludec), a once-daily new-generation basal insulin analogue with an ultra-long duration of action, and NovoRapid (insulin aspart which in the U.S. is marketed under the brand name NovoLog). Ryzodeg can be administered once or twice daily with the main meal(s).

In global treat-to-target studies supporting the new drug application, where Ryzodeg was compared to NovoMix, Ryzodeg demonstrated a significantly lower risk of nocturnal hypoglycemia while successfully achieving equivalent reductions in HbA1c.

In Japan, Ryzodeg will be available in FlexTouch, Novo Nordisk’s latest prefilled insulin pen, which has an easy auto-injector mechanism, and in Penfill for Novo Nordisk?s durable insulin pens.

Tresiba and Ryzodeg were submitted for regulatory approval to the Japanese Ministry of Health, Labor and Welfare in December 2011 and March 2012, respectively. Tresiba was approved in Japan in September 2012. In October 2012, Tresiba and Ryzodeg received positive CHMP opinions in the EU. In November, the products received a positive vote for approval from an FDA Advisory Committee. In addition, applications have been submitted for regulatory approval in Canada, Switzerland and a range of other countries.

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More than two years after dealing Novo Nordisk a surprising setback, the U.S. Food and Drug Administration has approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection)…

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